NHS Trust /
Wolverhampton Shared Care Agreement / Wolverhampton City
Clinical Commissioning Group
Methylphenidate, Dexamphetamine, Atomoxetine and Lisdexamfetamine
ESCA: For the treatment of Attention Deficit Hyperactivity Disorder in children
SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
Patient’s Name: / NHS Number:Date of Birth: / Date Treatment Started:
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number:
PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER
I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with this medicine (*delete as appropriate)GP Name:
Signature: / Date:
Once signed please detach this sheet and fax to the number shown above.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.
BACK-UP ADVICE AND SUPPORT
Contact details / Telephone No. / Fax: / Email address:Specialist: Dr M Sawal (Paediatrics) / 01902444347 / 01902 446289
Specialist: Dr C Higgins (Paediatrics) / 01902 444325 / 01902 446289 /
Specialist: Dr C Ramalingam (Paediatrics) / 01902 444021 / 01902 446289 /
Specialist: Dr S Simon (Paediatrics) / 01902 444341 /
Specialist: Dr V. Pemmaraju (CAMHS) / 01902 444021 /
Hospital Pharmacy Department / 01902 695136 /
Patient’s Name: Date Of Birth: Date treatment commenced:
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
The aim of Effective Shared Care Agreements (ESCA) is to provide information to general practitioners (GPs) and hospital staff about complex or high cost therapies that their patients may receive following specialist referral. An ESCA will only be written when it has been agreed that shared care is an appropriate option, and will include a statement of Specialist Unit / GP responsibilities.
Shared Care Guidelines will ensure that all GPs have sufficient information to enable them to undertake prescribing responsibility for specialist therapies and other therapies that may affect / interact with specialist therapies.
It is not the intention to insist that GPs prescribe this therapy and any doctor who does not wish to undertake the clinical and legal responsibility for this drug is not so obliged. Acceptance of the Effective Shared Care Agreements will be endorsed by the Prescribing Support Board and drugs will, where appropriate, be added to the list of high cost drugs used when setting prescribing budgets.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use.
RESPONSIBILITIES and ROLES
Specialist responsibilities1. Arrange comprehensive assessment of the child and be responsible for making the diagnosis, considering other possible diagnoses, comorbidity and contraindications to treatment
2. Initiate treatment and stabilise the patient on methylphenidate or other appropriate treatment
3. Inform GP promptly about changes to treatment, dosage adjustments and the assessment of adverse events
4. Review the patient's condition and monitor response to treatment regularly, and keep GP informed
5. Arrange on-going monitoring of height, weight and blood pressure at 1 month, then at 6 monthly intervals
6. Arrange periodic full blood counts when indicated
7. Provide written guidance for parents and teachers, regarding drug treatment at specialist’s discretion
8. Advise the GP regarding rapid referral of a patient in the event of deteriorating clinical condition, and provide advice about when and how to stop treatment
9. Back up advice on any of the above will be available at all times
10. Report adverse events to the on the MHRA yellow card reporting system
General Practitioner responsibilities
1. Prescribing methylphenidate or other medication once notified by specialist that the patient is showing a response to treatment
2. Ensuring that treatment is not continued indefinitely where the patient has ceased attending the specialist clinic. GP will be notified of non-attendance by the specialist.
3. Reporting to and seeking advice from the specialist on any aspect of patient care which is of concern to the GP and may affect treatment
4. Refer back to specialist if condition deteriorates
5. Report adverse events to specialist and on the MHRA yellow card reporting system
6. Stop treatment on advice of specialist
Patient's role
1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
2. Completing questionnaires given by Specialist in order to report on treatment, efficacy and tolerance
3. Putting into practice any behaviour / psychology programmes that are suggested by the specialist’s team, and reporting on their effectiveness
4. Report any adverse effects to the specialist or GP
SUPPORTING CLINICAL INFORMATION
Indications
Methylphenidate, dexamphetamine and atomoxetine (Strattera) are licensed for the treatment of ADHD in the UK. They should form part of a comprehensive treatment programme for ADHD, where remedial measures alone prove insufficient and are recommended by NICE guidance (TA98). They are not currently licensed for use in children less than 6 years old but are now licensed for adults provided treatment was started in childhood. Methylphenidate and dexamphetamine are controlled drugs, atomoxetine is not.
Treatment aims in Attention Deficit Hyperactivity Disorder (ADHD) are to reduce hyperactive behaviour, detect and treat any co-existing disorders, promote academic and social learning, improve emotional adjustment and self-esteem, and to relieve family distress.
ADHD is defined by ‘core’ signs of inattention, hyperactivity and impulsiveness. A child may present with one or more of these signs. In order to make a diagnosis the following criteria must be satisfied:
· The signs must have persisted for at least 6 months to a degree that is maladaptive and inconsistent with the developmental level of the child.
· There must be clear evidence of clinically significant impairment in social or academic functioning
· Impairment is present in two or more settings (usually at home and school)
· Some of the signs that caused impairment were present before the age of seven
· The signs do not occur exclusively during the course of other developmental or mental disorder, and are not better accounted for by another diagnosis.
Current treatments for ADHD include a range of social, psychological and behavioural interventions involving the child, parents, teachers, and health professionals. These vary from the provision of information and advice, through to formal psychotherapeutic interventions. There may be need for dietary intervention where a parent has observed that a particular food aggravates the symptoms.
Medications that are currently licensed for the treatment of ADHD in the UK are the CNS stimulants methylphenidate and dexamphetamine and the non-stimulant atomoxetine. Some clinicians prescribe antidepressants and anxiolytics to treat co-morbidities in this condition.
Dosage and Administration
Immediate Release preparations of Methylphenidate (e.g. Ritalin® or Medikinet®)
Starting dose is 5mg once or twice daily. The dose may then be increased by 5-10mg, at intervals of not less than one week. Doses above 60mg daily are not recommended. Timing of doses is important as effects will be observed within 15 to 20 minutes and will last for 3-4 hours. As the drug is likely to have an effect on appetite doses should be given after meals. If the effects of the drug wear off too early in the evening, a small early evening dose (as advised by the specialist) may be necessary to avoid disturbed behaviour and inability to sleep. If improvement of symptoms is not observed after one month at an appropriate dose, it is advisable that the drug is discontinued. Methylphenidate should be discontinued periodically (under specialist supervision) to assess the child’s condition and need for continued treatment.
Modified Release Preparations of Methylphenidate
Concerta® XL ▼: The initial dose is 18mg once daily in the morning after breakfast, increased if necessary in weekly steps of 9-18mg according to response. The maximum daily dose is usually 72mg once daily. Recommendations for continuing and reviewing treatment are as above. Concerta® XL has a duration of action of up to 12 hours – it must be swallowed whole with the aid of liquids and must NOT be chewed, divided or crushed.
Equasym XL; Medikinet XL: The initial dose is 10mg once daily in the morning after breakfast. The dose may be increased gradually to a maximum daily dose of 60mg. Follow directions above for continuation/review of prescribing. Equasym XL and Medikinet XL have a shorter duration of action than Concerta XL and are often used for younger children.
Medikinet XL and Equasym XL – contents of capsule can be sprinkled on a tablespoon of apple sauce, then swallowed immediately without chewing followed by a drink of fluid e.g. water. (see SPC / BNFC for more information)
Dexamfetamine can be used in those who fail to respond to methylphenidate. The starting dose is 2.5mg once or twice a day, increased at weekly intervals by 2.5 - 5mg daily to maximum of 40mg daily given in 2-4 divided doses. Generally the dose is half that of methylphenidate.
Lisdexamfetamine (Elvanse®): The initial dose is 30mg once a day in the morning and may be increased by 20mg increments at approximately weekly intervals. The maximum dose is 70mg once daily. Swallow whole or mix contents of capsule in yoghurt or a glass of water or orange juice; disperse contents completely and consume immediately.
Atomoxetine (Strattera®): A non-stimulant medication which can provide 24 hour control of symptoms but can take up to 12 weeks for benefits to be apparent. The initial dose is 0.5mg/kg daily increased after 7 days to 1.2mg/kg or 1.8mg/kg daily according to response. The total daily dose may be given either as a single dose in the morning or in 2 divided doses with the last dose no longer than early evening. The capsules are not intended to be opened (ocular irritant).
Contraindications
All these drugs are contraindicated in patients who are anxious or agitated or develop severe depression or suicidal ideation. They may also be contraindicated in patients with motor tics, tics in siblings, or a family history or diagnosis of Tourette’s syndrome and may lower seizure threshold.
They should not be used with hyperthyroidism, severe angina pectoris, cardiac arrhythmias (e.g. long QT syndrome), hypertension, glaucoma, thyrotoxicosis, phaeochromocytoma or known sensitivity.
Side Effects
The most common side-effects reported with methylphenidate treatment in trials were insomnia, decreased appetite, stomach ache and headache. The latter three are usually mild and transient. Insomnia may be controlled by altering the dosage times. There is little evidence to suggest that long term treatment suppresses height and weight gain.
A full list of potential adverse effects is given in the BNF and in Compendium of Data Sheets and Summaries of Product Characteristics.
Parents/carers and teachers may be given side-effect questionnaires from the specialist to enable them to monitor how the patient tolerates methylphenidate.
Monitoring
Patients requiring long term therapy should be monitored carefully. The patient’s response to the drug is assessed by the Specialist at each clinical meeting. Parent and teacher reports on levels of activity, concentration, and other factors are compared before and after treatment and facilitate the decision to increase the dose or stop treatment.
Height, weight and blood pressure to be measured every 6 months and any adverse findings/trends should be notified to the specialist as soon as possible. Methylphenidate has been shown to cause leucopenia, thrombocytopenia and anaemia (12 reports since 1964). A full blood count should be done urgently if any of these conditions are suspected.
Drug Interactions
Methylphenidate may inhibit the metabolism of coumarin anti-coagulants, some anticonvulsants (e.g. phenobarbitone, phenytoin, primidone), tricyclic anti-depressants, and phenylbutazone; the dosage of these drugs may have to be reduced. Methylphenidate should be used in caution with patients receiving MAOIs as there is a risk of hypertensive crisis but these drugs are rarely used in children.
Version Control
Version / Date of Issue / Author/s / Brief Description of Changes
1.0
This shared care agreement has been approved for use in Wolverhampton by: / Signature / Date
RWT MMC Chairman / Dr S Cherukuri / / 21/07/2015
Wolverhampton City CCG Prescribing Lead / Dr J Parkes / / 21/07/2015
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics for the relevant products and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS October 2002).
Date approved: 21/07/2015 Expiry date: 21/07/2018